NCT07337538

Brief Summary

The goal of this clinical trials is to compare two diameters, 1.6 and 2 mm, of mini implants both are 12 mm length placed in the infrazygomatic crest region. The main questions it aims to answer are: which diameter is more suitable for IZC region 1.6 or 2mm in terms of primary stability, secondary stability, pain perception and failure rate. 20 participant will receive 40 mini implant bilaterally (20 in one side of 1.6mm, the other side 20 of 2mm). participants will be asked to record visual analog scale (VAS) for 3 nights monitored monthly by the investigator.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
6mo left

Started Jan 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress39%
Jan 2026Nov 2026

First Submitted

Initial submission to the registry

January 1, 2026

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 13, 2026

Completed
1 day until next milestone

Study Start

First participant enrolled

January 14, 2026

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2026

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2026

Last Updated

January 20, 2026

Status Verified

January 1, 2026

Enrollment Period

8 months

First QC Date

January 1, 2026

Last Update Submit

January 15, 2026

Conditions

Implant Stability

Keywords

temporary anchorage device stabilityTadsmini implantminiscrew

Outcome Measures

Primary Outcomes (2)

  • primary stability

    primary stability measurement using easy check device (Dentium, south Korea) giving range of (1 - 100).

    immediately after insertion

  • secondary stability

    secondary stability measurement using easy check device (Dentium, south Korea) giving range of (1 - 100).

    two month after insertion.

Secondary Outcomes (2)

  • pain perception

    after insertion 24 hour, 48 hour, 72 hour.

  • Failure rate

    monthly for six months after insertion.

Study Arms (2)

1.6 mm

EXPERIMENTAL

1.6 x12 mm mini implant inserted in the infrazygomatic crest region according to split mouth allocation.

Device: insersion of two diameters of mini implant.

2 mm

EXPERIMENTAL

2 x12 mm mini implant inserted in the infrazygomatic crest region according to split mouth allocation.

Device: insersion of two diameters of mini implant.

Interventions

insersion of two diameters of mini implant.DEVICE

insertion of the two diameters in the infrazygomatic crest region (IZC) bilaterally (one for each side) then check difference in primary stability, secondary stability, pain perception and failure rate.

1.6 mm2 mm

Eligibility Criteria

Age15 Years - 38 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Individuals aged between 15 and 38 years.
  • Patients currently undergoing orthodontic treatment with fixed appliances who require mini-implant placement in the upper buccal posterior region (IZC) for full-arch distalization or en-masse retraction.
  • Patients willing and able to adhere to the study protocol.
  • Recommended for the use of bilateral mini-implants.

You may not qualify if:

  • Syndromic conditions, facial trauma, or previous bone-related surgery.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Saydiya dental clinic

Baghdad, Baghdad Governorate, 10017, Iraq

NOT YET RECRUITING

Baghdad university

Baghdad, Baghdad Governorate, 10047, Iraq

RECRUITING

MeSH Terms

Conditions

Tietz syndrome

Study Officials

  • Ali J. Al Ameri, BDS.

    University of Baghdad

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ali J. Al Ameri, BDS.

CONTACT

+9647775039229Ali.Fahd2403@codental.uobaghdad.edu.iq

Mehdi A. Alrubayee, PHD.

CONTACT

+9647703909151mehdi.a.151@codental.uobaghdad.edu.iq

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participants will be blinded to the diameter of the mini-implants placed on each side. The investigator performing the insertion will not be blinded due to the obvious difference in implant diameter.
Purpose
DEVICE FEASIBILITY
Intervention Model
CROSSOVER
Model Details: 20 participants will be enrolled. Each participant will receive two interventions concurrently, with a 1.6-mm diameter mini-implant placed on one infra-zygomatic crest and a 2.0-mm diameter mini-implant placed on the contralateral side. The side allocation of implant diameter will be randomized in an alternating manner (left-right).
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
student researcher

Study Record Dates

First Submitted

January 1, 2026

First Posted

January 13, 2026

Study Start

January 14, 2026

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

November 1, 2026

Last Updated

January 20, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

IR(2)